Preparation for the
FDA Advisory Committee is a process that should parallel product development. Since there has already been significant time and money invested in to develop the product in a review, manufacturers must be able to support their product in this highly visible, high-stakes public meeting. One of the most challenging experiences for any team to experience is appearing before an
FDA Advisory Committee, which is why it is important to be prepared for all and any questions regarding the product in review.
At our
FDA Advisory Committees Strategy Summit, you will receive a better understanding of how to enhance the Likelihood of a Successful Panel Meeting with the
FDA through strategic planning.
Key Event Takeaways
- Navigate Advisory Committee preparation from a safety and pharmacovigilance standpoint
- Understand the roles of Advisory Committee membership types
- Set the stage for a successful launch with practical models of preparation
- Instill best practices for regulatory submissions
- Adhere to regulatory updates and standards
Who Should Attend
Primary Audience
- Regulatory Affairs
- Regulatory Submissions
- Regulatory Operations
- Regulatory Compliance
- Regulatory/Medical/Clinical/Technical Writing
- Medical and Clinical Affairs
- Clinical Development
- Clinical Operations
- Clinical Research Lead
- Safety/Product Safety/Drug Safety
- Product Development
- Pharmacovigilance
- Biostatistics
- Legal/Counsel
- Corporate Executives
Secondary Audience
- Consultants
- Technology Vendors
Speakers
- Aden Asefa, MPH, Regulatory Health Project Manager, U.S. FOOD AND DRUG ADMINISTRATION
- Dr. Elizabeth Garner, Chief Medical Officer, Senior Vice President Clinical Development, AGILE THERAPEUTICS
- Scott Greenfeder, Head, Oncology Regulatory Affairs Group 2, BAYER
- Dr. Dennis E. Hruby, Chief Science Officer, SIGA TECHNOLOGIES
- Michelle Lott, RAC, Principal and Founder, Lean RAGA Systems and Industry Representative, FDA DEVICE GOOD MANUFACTURING PRACTICES ADVISORY COMMITTEE (DGMPAC)
- Diane Murphy, MBA, Director, Clinical Development, ALLERGAN
- Stefan Ochalski, Ph.D., MBA, Vice President, Regulatory Affairs, TAIHO ONCOLOGY, INC.
- Craig Ostroff, PharmD, R.Ph., Vice President and Head, Cardiovascular and Metabolic Disease Areas, Global Regulatory Affairs, JANSSEN, Pharmaceutical Companies of, JOHNSON & JOHNSON
- Rachael Carlisle Roehrig, Ph.D., Executive Scientific Strategist, 3D COMMUNICATIONS, LLC
- Michael Rozycki, Ph.D., Vice President, Regulatory Affairs, PACIRA PHARMACEUTICALS, INC.
- Jim Wang, PhD, MBA, Head of Regulatory Strategy, SPARK THERAPEUTICS
- Kristin Zielinski Duggan, Adjunct Professor, FDA Regulation of Medical Products, GEORGETOWN UNIVERSITY
Please fill in your name and email to receive the conference agenda of this event.
Conference Day One - Monday, 5 November 2018
Conference Day Two - Tuesday, 6 November 2018
Venue
Hilton Washington Dulles Airport
13869 Park Center Rd, 20171
Herndon, VA, USA
Venue
Hilton Washington Dulles Airport13869 Park Center Road
Herndon, VA 20171
To make reservations, please call 703-478-2900 and request the negotiated rate for ExL November Meetings. You may also make reservations online using the following weblink:
Click HereThe group rate is available until October 15, 2018. Please book your room early, as rooms available at this rate are limited.
